We at EPM HQ, with the help of ramarketing, caught up with Uwe Hanenberg, Head of Product Development, Oral Solid Dose, Recipharm to discuss all things OSD!

EPM: You’ve recently announced investment in your new analytical lab, can you tell me the benefits that the lab’s testing capabilities will offer your customers?

Uwe: Our new analytical lab investment offers customers advanced testing capabilities, ensuring product safety and quality. It enables:

a.  Extractables and leachables (E&L) analysis:

• The US Food & Drug Administration’s (FDA)increasing regulation of medical device materials highlights the importance of extractables, leachables, and impurity studies, especially regarding adhesive-specific impurities, such as acrylate monomers. These can be allergenic and require evaluation for medical device and drug applications.
• Advanced methodologies for extractables testing are employed, as E&L testing necessitates meticulous control over extraction, analysis, and precise identification processes. This ensures the comprehensive examination of potential substances that might migrate from materials into the final product.

b.  Elemental impurities identification:

• Compliant workflows and instrumentation for determining elemental impurities in drugs, adhering to USP 232 and ICH Q3D guidelines.

c.    Highly sensitive nitrosamines detection:

• The lab ensures strict compliance with safety standards, particularly in pharmaceuticals and cosmetics, by detecting even trace levels of nitrosamines, potent carcinogens that can be impurities in drug products.

d.  Identification of unknown impurities including non-volatile organic impurities, semi-volatile organic impurities

• Unambiguous identification of organic volatile impurities in active pharmaceutical ingredients (APIs), intermediates, or excipients and drug products.

EPM: What are the recent trends you’re seeing in the OSD market? E.g. where is demand coming from, and what new technologies are emerging?

Uwe: The outsourcing trend continues, and we’re seeing demand come from small, medium and large pharma. We’re also seeing high activities and engagement in oral biologics; the increasing application of data science; and interest in collaboration in oral solid dose continuous manufacturing.

EPM: What are the main challenges currently facing CDMOs when it comes to OSD formulation?

Uwe: In product development, we are facing high pressure on timelines and cost. This is in addition to overcoming the scientific challenges that come with product development and preparing for robust clinical and commercial manufacturing.

In tech transfers the main challenges are related to non ”like to like” transfer to the same equipment type at the same scale. This is likely to occur in almost every tech transfer.

Such challenges can be overcome with a combination of risk assessment and data analysis of material, process and equipment differences followed by scientific trial planning. When applied correctly and executed with discipline it will always lead to a very good understanding of the design space and to a robust process. The key to success is professional and structured project management.

EPM: What advancements do you predict we’ll see in the OSD space over the coming years?

Uwe: Data science will influence all aspects of pharmaceutics, from development (more in silico work) operations and engineering (optimal facility planning) to QA (holistic view on product quality). This will lead to shorter time frames from early development to commercial. In routine production, data science will help to reduce deviations and scrap production, and will help significantly in optimal planning, leading to higher on time in full delivery, with higher robustness at lower cost. Quality systems will be more efficient, 

EPM: CDMOs are under constant pressure from customers to accelerate the tech transfer process. How is Recipharm able to support its customers on their commercial scale quality and production goals for their projects?

Uwe: Recipharm is well-equipped to support its customers in achieving their commercial scale quality and production goals for their projects. Here’s how:

Global project management: Recipharm is implementing a global project management organisation with the aim of standardising tech transfer processes and increasing their efficiency. This established global PM structure works with the local teams within Recipharm to provide state-of-the-art tech transfer processes.

• Efficiency and resource leverage: The aim of these processes is to reduce hands-on time, increase efficiency, and enable the leverage of resources across the organisation. This means that projects can be completed more quickly and effectively, saving both time and money.
• Experience: Recipharm has a long history of performing tech transfer between its own sites as well as to and from third parties. This experience allows us to understand how to scale-up, tech transfer, and validate processes rapidly with a focus on product quality.
• Comprehensive support: Recipharm supports all aspects of the techtransfer process, from consideration of the equipment available at the new site, understanding critical process parameters, to handover of manufacturing and quality control methods. This ensures the transfer process is as smooth and seamless as possible.
• Transparency: Recipharm believes in complete transparency during the tech transfer process. All process documentation, including successful runs and any failures or issues, are made fully transparent between parties to ensure complete information transfer.
• Smooth transfers: Recipharm has a track record of smooth tech transfers, which means customers can trust the company to onboard their small and large molecule projects without mess or fuss.

By providing these services, Recipharm is able to help its customers accelerate the tech transfer process and meet their commercial scale quality and production goals.

EPM: How is Recipharm able to guarantee commercial supply for its customers?

Uwe: Recipharm has established a capacity-based, state-of-the-art Industry S&OP (Sales and Operations Planning) Process, which ensures we are ready to execute on every confirmed order with certainty. The visibility we have about all our production lines allows to react to short-term, mid-term and long-term capacity with highest flexibility

EPM: Can you tell me how Recipharm is adopting digital science in its product development processes?

Uwe: In OSD, Recipharm is adopting digital science and application of statistical and in silico tools e.g in the measurement and evaluation of physical characterisation of APIs and excipients. The aim is to understand the correlation between material properties, the production process and quality attributes of the product.

When it comes to tech transfers, digital tools are used for analysis of historical data (e.g. batch manufacturing data and related analytical results) to understand the critical parameters of material and process and their impact on product quality.

EPM: Do you have any predictions for how digital science advancements will evolve in the future?

Uwe: We predict that data science will evolve to data platforms which will be used with Machine Learning and Artificial Intelligence Tools. The next few years will be characterised by the implementation of such systems in almost all functions of the pharmaceutical industry.